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Muscle Function Assessment for Postpartum Women

N/A
Recruiting
Led By Bryan Heiderscheit, PT, DPT, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Prescription anti-inflammatory/pain medications that are taken daily
Neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 days
Awards & highlights

Summary

This trial will study how well a woman can control her lower body and trunk muscles after giving birth, as well as how active she is. There will be two sessions, a week apart, to test this.

Who is the study for?
This trial is for women who have recently given birth to their first child and are experiencing muscle weakness or fatigue. They should not be on daily anti-inflammatory/pain medications, have significant orthopedic conditions, previous abdominal surgeries (except Cesarean), or any neuromuscular health issues.Check my eligibility
What is being tested?
The study will use ultrasound imaging and various physical tests to assess the muscle function of the lower body and abdomen in new mothers. Participants will attend two sessions about a week apart to measure their neuromuscular control.See study design
What are the potential side effects?
There may be minimal side effects from this study as it involves non-invasive testing such as ultrasound imaging and physical strength assessments. However, some discomfort during testing due to exertion might occur.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I take prescription anti-inflammatory or pain medication daily.
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I have a condition affecting my nerves or muscles, like diabetes or MS.
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I do not have severe bone conditions that would prevent me from performing physical tasks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abdominal Fascial Integrity Measured by Mean Inter-Recti Distance
Incidence of Lumbopelvic Instability
Incidence of Perceived Difficulty with ASLR Task
+5 more
Secondary outcome measures
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)
Average Minutes per Day of Activity in at least 10-minute bouts
+15 more
Other outcome measures
Mean discharge rate of single motor units
Percent of Maximum Voluntary Isometric Contraction (MVIC)
Root mean square (RMS) of global EMG

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PostpartumExperimental Treatment4 Interventions
Participants who are six months postpartum will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless Electromyography (EMG) sensors will be used to record EMG and limb steadiness (via Inertial Measurement Units (IMU). Physical activity will be measured by questionnaire and accelerometer.
Group II: NulligravidActive Control4 Interventions
Participants who have never been pregnant will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless EMG sensors will be used to record EMG and limb steadiness (via IMUs). Physical activity will be measured by questionnaire and accelerometer.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,198 Previous Clinical Trials
3,162,186 Total Patients Enrolled
1 Trials studying Muscle Weakness
80 Patients Enrolled for Muscle Weakness
Carroll UniversityOTHER
Bryan Heiderscheit, PT, DPT, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Active Straight Leg Raise Fatigue Task Clinical Trial Eligibility Overview. Trial Name: NCT05073224 — N/A
Muscle Weakness Research Study Groups: Postpartum, Nulligravid
Muscle Weakness Clinical Trial 2023: Active Straight Leg Raise Fatigue Task Highlights & Side Effects. Trial Name: NCT05073224 — N/A
Active Straight Leg Raise Fatigue Task 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073224 — N/A
~3 spots leftby Sep 2024